UNASSIGNED: Treatment of calcified lesions with conventional angioplasty balloons can be difficult due to insufficient lumen expansion, high dissection rates, and repeated revascularization. We report a case in which a scoring balloon was used in lesions resistant to angioplasty with a semi-compliant balloon.
UNASSIGNED: A 72-year-old man presented with severe stenosis and a highly calcified lesion in the right cervical internal carotid artery. Right carotid artery stenting (CAS) was planned to prevent future ischemic stroke events. Conventional semi-compliant balloon angioplasty was unsuccessful. Three inflations of a non-slip element (NSE) percutaneous transluminal angioplasty (PTA) scoring balloon (Nipro, Osaka, Japan) successfully achieved CAS without complications.
UNASSIGNED: This is the first report to describe the use of this scoring balloon in de novo carotid artery disease. NSE PTA scoring balloon catheters can be a useful option for refractory, highly calcified stenosis.

Safety and feasibility of transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) using the SAPIEN 3 balloon-expandable device has been previously demonstrated. The impact on long-term valve hemodynamic performances and outcomes remains however unknown. We evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVR vs BAV pre-TAVR) in patients included in the DIRECTAVI randomized trial (NCT02729519).
Clinical and echocardiographic follow-up until January 2023 was performed for all patients included in the DIRECTAVI trial since 2016 (n = 228). The primary endpoint was incidence of moderate/severe hemodynamic valve deterioration (HVD), according to the Valve Academic Research defined Consortium-3 criteria (increase in mean gradient ≥10 mmHg resulting in a final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade resulting in ≥ moderate aortic regurgitation).
Median follow-up was 3.8 (2.2-4.7) years. Mean age at follow-up was 87 ± 6.7 years. No difference in incidence of HVD in the direct implantation group compared to the BAV group was found (incidence of 1.97 per 100 person-years and 1.45 per 100 person-years, respectively, P = 0.6). Prevalence of predicted prothesis-patient mismatch was low (n = 13 [11.4%] in the direct TAVR group vs n = 15 [13.2%] in BAV group) and similar between both groups (P = .7). Major outcomes including death, stroke, hospitalization for heart failure and pacemaker implantation were similar between both groups, (P = .4, P = .7, P = .3, and P = .3 respectively).
Direct implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up. These results guarantee wide use of direct balloon-expandable valve implantation, when feasible.
NCT05140317.

This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines.

OBJECTIVE: Whether direct stenting (DS) without predilatation during primary percutaneous coronary intervention (PPCI) reduces microvascular dysfunction in patients with ST-elevation myocardial infarction is unclear. We performed a randomized study to assess the effect of DS on microvascular reperfusion.
METHODS: Seventy-two patients undergoing PPCI were randomly assigned to the DS or conventional stenting (CS) with predilatation groups. The primary endpoint was the post-PPCI index of microcirculatory resistance (IMR). We compared thrombolysis in myocardial infarction myocardial perfusion (TMP) grades, ST-segment resolution, and long-term clinical outcomes between the groups.
RESULTS: Microvascular reperfusion parameters immediately after PPCI (e.g., the IMR, TMP grade, and ST-segment resolution) were not different between the groups. However, significantly fewer patients in the DS group had the IMR measured because of no-reflow or cardiogenic shock during PPCI than those in the CS group. No differences were found in left ventricular functional recovery or clinical outcomes between the groups.
CONCLUSIONS: This trial showed no effect of DS on the IMR. However, our finding should be interpreted with caution because the number of patients who could not have the IMR measured was higher in the CS group than in the DS group. A larger randomized trial is required (Research Registry number: 8079).

Annular rupture is a rare and dreaded complication of transcatheter aortic valve replacement (TAVR) and even rarer when caused by predilatation balloon aortic valvuloplasty. This complication often presents as sudden cardiac tamponade with hypotension and requires urgent intervention. The traditional rescue strategy for patients with annular rupture is emergency surgical repair. However, the mortality rate is still high, considering that most patients who undergo TAVR are not candidates for conventional cardiac surgery. Therefore, there is a need for additional emergency treatment strategies to decrease mortality. This report describes a case of predilatation-induced annular rupture during TAVR that was successfully sealed at the rupture site by valve implantation. This case suggests that continuing with valve deployment may be a successful treatment for predilatation-induced annular rupture during TAVR.

BACKGROUND: This study aimed to evaluate the differences in outcome arising from the use of semi-compliant (SCB) versus non-compliant balloon (NCB) systems for predilatation during self-expanding transcatheter aortic valve replacement (TAVR).
METHODS: 251 TAVR procedures with the implantation of self-expanding valves after predilatation were analyzed. SCB systems were used in 166 and NCB systems in 85 patients. The primary endpoint was defined as device success, a composite endpoint comprising the absence of procedural mortality, correct valve positioning, adequate valve performance and the absence of more than a mild paravalvular leak. The secondary endpoints were chosen in accordance with the valve academic research consortium (VARC-2) endpoint definitions.
RESULTS: No significant differences were observed with regard to procedural device success between the SCB- and NCB cohort (SCB: 142 [85.5%%] vs. NCB: 77 [90.6%]; P = .257). There was a notable difference between the rates of conversion to open surgery and the postdilatation rate, both of which were higher for the NCB group (SCB: 1 [0.6%] vs. NCB: 4 [5.1%]; P = .042; SCB: 30 [18.1%] vs. NCB: 34 [40%]; P < .001). In a multivariate logistic regression analysis, the use of semi-compliant balloon systems for predilatation was associated with a lower risk for postdilatation (OR: 0.296; 95% CI: 0.149-0.588) and conversion to open surgery (OR: 0.205; 95% CI: 0.085-0.493; P = .001) but not for device success.
CONCLUSIONS: While the balloon compliance did not affect the procedural mortality, device success or the rate of paravalvular leakage, the use of semi-compliant balloons for predilatation during TAVR should be investigated in larger randomized trials in the light of the lower rates of postdilatation and conversion to open surgery compared to their non-compliant counterparts.

BACKGROUND: This systematic review and meta-analysis aimed to evaluate the efficacy and safety of direct vs preimplantation balloon valvuloplasty (predilatation) before transcatheter aortic valve replacement (TAVR).
METHODS: We performed a systematic literature search up until March 2020 from PubMed, SCOPUS, EuropePMC, Cochrane Central Database, ProQuest, and ClinicalTrials.gov. We included randomized controlled trial (RCT) and prospective-matched cohorts that compared direct TAVR and preimplantation balloon valvuloplasty before TAVR. The primary outcome was the device success as defined by Valve Academic Research Consortium 2. The secondary outcome was a patient-prosthesis mismatch, the need for balloon postdilatation, composite adverse events, and 1-year mortality.
RESULTS: There were a total of 3078‬ patients from eight studies. This meta-analysis showed that direct TAVR has a similar device success rate (P = .63), the need for postdilatation (P = .82), and composite adverse events (P = .98) compared with preimplantation balloon valvuloplasty. Subgroup analysis for balloon-expandable valves showed lower need for balloon postdilatation (risk ratio [RR], 0.63 [0.47, 0.84]; P = .002; I2 , 0%) in direct TAVR group but higher incidence of acute kidney injury (RR, 3.23 [1.25, 8.40]; P = .02; I2 , 0%) and major/life-threatening bleeding (RR, 1.54 [1.17, 2.02]; P = .002; I2 , 0%). Subgroup analysis for the RCTs alone and RCTs + propensity-matched cohorts showed similar device success and composite adverse events in both groups. However, pooled RCTs showed a higher need for balloon postdilatation in direct TAVR (RR, 1.83 [1.03, 3.24]; P = .04; I2 , 0%).
CONCLUSIONS: Direct TAVR has similar efficacy and safety to preimplantation balloon valvuloplasty. However, better-designed RCTs are required before drawing a definite conclusion.

This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter.
Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular.
We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon.
Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker.
Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.

Predilatation has been historically considered a mandatory step before transcatheter aortic valve implantation (TAVI) since it facilitates valve crossing and prosthesis delivery, ensures optimal valve expansion and improves hemodynamic stability during valve deployment. However, as a result of procedural evolution over time, direct TAVI (without pre-implantation balloon aortic valvuloplasty) has emerged as an interesting option to simplify the procedure and to avoid potential valvuloplasty-related complications. Several real-world retrospective studies and one small randomised study have shown that direct TAVI (with both self-expanding and balloon-expandable prostheses) is feasible, safe and associated with outcomes similar to standard TAVI with pre-implantation balloon aortic valvuloplasty. In the absence of high-quality, robust evidence, the current review aims to discuss the advantages and disadvantages of omitting predilatation prior to TAVI.

OBJECTIVE: Studies conducted across the world have reported that the rates of major adverse cardiac events (MACE) following the use of bioresorbable vascular scaffolds (BVS) are comparable to that noted with traditional drug eluting stents (DES). However, there is limited data on the immediate and medium-term clinical outcomes following the use of the Absorb BVS (Abbott Vascular, Santa Clara, SA) in the Indian context. This study was conducted to determine real-world evidence on the immediate and medium-term clinical outcomes in all patients undergoing percutaneous coronary intervention (PCI) with the Absorb BVS.
METHODS: Data of all patients who were treated with Absorb BVS at our center were evaluated. Between December 2012 and October 2016, 142 patients underwent PCI with BVS. The MACE rates during hospitalization, at 30days, 3 months, 6 months after PCI, and every 6 months thereafter were the primary endpoints evaluated with median follow up of 13 months.
RESULTS: Mean age of the study participants was 53.7±11.8years. Intravascular ultrasound imaging was performed in 15.34% of patients. Predilatation and postdilatation were performed in 81.8% and 84.6% of scaffolds, respectively. There were no episodes of MACE during hospitalization. However, 1 BVS-related MACE was observed at the 1-month (0.7%) as well as at the ≥12 month (0.8%) follow up visits. At the 6- and 12-month follow up visits, 2 (1.5%) and 3 (2.5%) non-BVS-related MACEs, respectively, were recorded.
CONCLUSIONS: The use of Absorb BVS in this real-world experience was associated with very good immediate and medium-term clinical outcomes.